- 1Q19 Net Sales Grew to $63.0 Million, a 29%
Increase Over 1Q18- Updated 2019 Net Sales Guidance to $280 Million
to $300 Million- Completed Enrollment in Two Late-Stage Adjunctive
Schizophrenia Studies with Pimavanserin
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system disorders, today announced its financial results for
the first quarter ended March 31, 2019.
“We’ve commenced 2019 with significant momentum. The commercial
initiatives implemented by our team have driven continued sales
growth of NUPLAZID,” said Steve Davis, ACADIA’s Chief Executive
Officer. “This past month, we initiated our Phase 3 CLARITY program
evaluating pimavanserin as an adjunctive treatment for patients
with major depressive disorder. We also completed enrollment in our
two schizophrenia studies and are on track to announce top-line
data from our ENHANCE schizophrenia inadequate response study
mid-year and top-line data from our ADVANCE schizophrenia negative
symptoms study around year-end 2019.”
Recent Highlights
- Initiated Phase 3 CLARITY program with
pimavanserin for adjunctive treatment in patients with major
depressive disorder (MDD) in April 2019.
- Completed enrollment in April 2019 in
our Phase 3 ENHANCE study evaluating pimavanserin as an adjunctive
treatment in schizophrenia inadequate response patients.
- Completed enrollment in April 2019 in
our Phase 2 ADVANCE study evaluating pimavanserin for adjunctive
treatment in schizophrenia negative symptoms patients.
- Announced the March 2019 Neurology®
publication of the positive Phase 2 study results for trofinetide
in pediatric Rett syndrome.
- Appointed Elena Ridloff, CFA, as
Executive Vice President and Chief Financial Officer in March
2019.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $63.0 million for the
first quarter of 2019, an increase of 29% as compared to $48.9
million reported for the first quarter of 2018.
Research and Development
Research and development expenses for the first quarter of 2019
were $52.9 million, compared to $39.3 million for the same period
of 2018. The increase was primarily due to additional clinical
study costs for pimavanserin as well as development costs for
trofinetide.
Selling, General and Administrative
Selling, general and administrative expenses for the first
quarter of 2019 were $93.1 million, compared to $60.9 million for
the same period of 2018. The increase was primarily due to an
increase in marketing expenses related to our direct-to-consumer
advertising campaign as well as increased charitable
contributions.
Net Loss
For the first quarter of 2019, ACADIA reported a net loss of
$85.3 million, or $0.59 per common share, compared to a net loss of
$54.3 million, or $0.44 per common share, for the same period in
2018. The net losses in the first quarter of 2019 and 2018
included $19.9 million and $20.4 million,
respectively, of non-cash stock-based compensation expense.
Cash and Investments
At March 31, 2019, ACADIA’s cash, cash equivalents, and
investment securities totaled $414.3 million, compared to $473.5
million at December 31, 2018.
2019 Financial Guidance
- ACADIA is updating 2019 NUPLAZID net
sales guidance to be between $280 million and $300 million from a
previous range of $275 million to $300 million.
- ACADIA reiterates GAAP R&D guidance
to be between $250 million and $265 million.
- ACADIA reiterates GAAP SG&A
guidance to be between $280 million and $295 million.
- ACADIA reiterates non-cash stock-based
compensation expense guidance to be between $80 million and $90
million.
Conference Call and Webcast Information
ACADIA management will review its first quarter financial
results and operations via conference call and webcast today at
4:30 p.m. Eastern Time. The conference call may be accessed by
dialing 855-638-4820 for participants in the U.S. or Canada and
443-877-4067 for international callers (reference passcode
6759227). A telephone replay of the conference call may be accessed
through May 8, 2019 by dialing 855-859-2056 for callers in the U.S.
or Canada and 404-537-3406 for international callers (reference
passcode 6759227). The conference call also will be webcast live on
ACADIA’s website, www.acadia-pharm.com, under the investors section
and will be archived there through June 1, 2019.
About NUPLAZID® (pimavanserin)
NUPLAZID is the first and only FDA-approved treatment for
hallucinations and delusions associated with Parkinson’s disease
psychosis. NUPLAZID is a non-dopaminergic, selective serotonin
inverse agonist (SSIA) preferentially targeting
5-HT2A receptors that are thought to play an important role in
Parkinson’s disease psychosis. NUPLAZID is an oral medicine taken
once a day with a recommended dose of 34 mg. ACADIA discovered and
developed this new chemical entity and holds worldwide rights to
develop and commercialize NUPLAZID.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development
and commercialization of innovative medicines to address unmet
medical needs in central nervous system disorders. ACADIA has
developed and commercialized the first and only medicine approved
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. ACADIA also has ongoing clinical
development efforts in additional areas with significant unmet
need, including dementia-related psychosis, schizophrenia
inadequate response, schizophrenia-negative symptoms, major
depressive disorder, and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include, but are not limited to, statements related to:
the potential opportunity for future growth in sales of NUPLAZID,
including through sales of new dosages and forms; the timing of
ongoing and future clinical studies for pimavanserin; the
development and commercialization of trofinetide; and guidance for
full-year 2019 NUPLAZID net sales and certain expense line items.
These statements are only predictions based on current information
and expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
uncertainty of future commercial sales and related items that would
impact net sales during 2019, the risks and uncertainties inherent
in drug development, approval and commercialization, and the fact
that past results of clinical trials may not be indicative of
future trial results. For a discussion of these and other factors,
please refer to ACADIA’s annual report on Form 10-K for the year
ended December 31, 2018 as well as ACADIA’s subsequent filings with
the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. This caution is made under the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. All forward-looking statements are qualified in their
entirety by this cautionary statement and ACADIA undertakes no
obligation to revise or update this press release to reflect events
or circumstances after the date hereof, except as required by
law.
ACADIA PHARMACEUTICALS INC. CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended March 31, 2019
2018 Revenues Product sales, net $ 62,959 $ 48,868
Total revenues 62,959 48,868
Operating expenses Cost of
product sales, license fees and royalties (1) 4,580 3,485 Research
and development (1) 52,923 39,276 Selling, general and
administrative (1) 93,090 60,926 Total operating
expenses 150,593 103,687 Loss from operations (87,634
) (54,819 ) Interest income, net 2,934 1,170 Other expense
(229 ) — Loss before income taxes (84,929 ) (53,649 ) Income
tax expense 375 647 Net loss $ (85,304 ) $ (54,296 )
Net loss per common share, basic and diluted $ (0.59 ) $ (0.44 )
Weighted average common shares outstanding, basic and diluted
143,981 124,727 (1) Includes the
following stock-based compensation expense Cost of product
sales, license fees and royalties $ 995 $ 1,050 Research and
development $ 7,880 $ 7,657 Selling, general and administrative $
11,008 $ 11,735
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31,
2019
December 31,
2018
(unaudited)
Assets Cash, cash equivalents and investment
securities $ 414,324 $ 473,520 Accounts receivable, net 29,958
26,090 Interest and other receivables 3,812 1,699 Inventory 4,570
4,070 Prepaid expenses 23,742 20,727 Total current
assets 476,406 526,106 Property and equipment, net 3,737 3,309
Operating lease right-of-use assets 10,918 — Intangible assets, net
3,692 4,062 Restricted cash 4,787 4,826 Other assets 1,565
1,899 Total assets $ 501,105 $ 540,202
Liabilities and
stockholders’ equity Accounts payable $ 3,275 $ 3,167 Accrued
liabilities 71,708 56,398 Total current liabilities
74,983 59,565 Operating lease liabilities 6,754 — Other long-term
liabilities 1,012 1,558 Total liabilities
82,749 61,123 Total stockholders’ equity 418,356
479,079 Total liabilities and stockholders’ equity $ 501,105
$ 540,202
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190501005863/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Mark Johnson,
CFA(858) 261-2771ir@acadia-pharm.com
Media Contact:ACADIA Pharmaceuticals Inc.Maurissa Messier(858)
768-6068media@acadia-pharm.com
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Sep 2023 to Sep 2024